Medical Device Certification Services

We support Medical Device Companies to achieve EU and USA Regulatory compliance. Our focus in in Software as Medical Device, and includes an holistic support on all the needs for expertise, from Technical Documentation (MDR(IVDR), Quality Management System (ISO 13485), Cybersecurity, Design and Development (IEC 62304), Risk Management (ISO 14971) AI Validation, Clinical Studies, Usability Studies, etc.